Key result
Rivaroxaban will be evaluated against warfarin for the prevention of stent occlusion in a planned randomized controlled trial of 224 patients with thrombotic left iliac vein compression syndrome.
Why the study?
Thrombosis may still occur after stent implantation for left iliac vein compression syndrome, and while warfarin requires long-term monitoring, rivaroxaban does not require laboratory monitoring and could simplify treatment.
Does rivaroxaban prevent stent occlusion compared to warfarin in patients with thrombotic left iliac vein compression syndrome treated with stent implantation?
RCT (n=224)
Open-label
Blocked central randomization
Yes
Does rivaroxaban prevent stent occlusion compared to warfarin in patients with thrombotic left iliac vein compression syndrome treated with stent implantation?
This study protocol outlines a randomized trial to evaluate whether rivaroxaban is non-inferior to warfarin for preventing stent occlusion in patients with thrombotic left iliac vein compression syndrome.
May simplify post-stent anticoagulation in LIVCS; leaves open whether rivaroxaban reduces occlusion versus warfarin.
BACKGROUND: Balloon dilatation with stent implantation has been proved to be an effective option for left iliac vein compression syndrome (LIVCS), but thrombosis may still occur after the operation. Currently, warfarin is used for anticoagulant therapy, but long-term monitoring is required, while rivaroxaban does not need laboratory monitoring, which can simplify treatment. Therefore, this study aimed to compare the efficacy and safety of rivaroxaban and warfarin in anticoagulation. METHODS: This study is a multicenter, randomized controlled trial. We will recruit 224 patients with thrombotic LIVCS from 9 hospitals. Moreover, these patients will be randomized to either the experimental group (rivaroxaban) or the control group (warfarin plus nadroparin). The primary outcome is stent occlusion rate. Secondary outcomes are quality of life scale survey results, all-cause mortality, anticoagulation-related mortality, and the proportion of participants with stent displacement/fracture, thrombosis, hemorrhage, and other vascular events. DISCUSSION: This study will provide reliable, evidence-based clinical evidence for the efficacy and safety of rivaroxaban antithrombotic therapy after stent implantation. TRIAL REGISTRATION: ClinicalTrials.gov NCT04067505 . Registered on August 26, 2019.
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Li et al. (2020) conducted an RCT in Left iliac vein compression syndrome (LIVCS) (n=224). Rivaroxaban vs. Nadroparin plus warfarin was evaluated on Stent occlusion rate. Rivaroxaban will be evaluated against warfarin for the prevention of stent occlusion in a planned randomized controlled trial of 224 patients with thrombotic left iliac vein compression syndrome.
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